Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 1
- 主要终点
- Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography
研究概览
简要总结
Sleep apnoea (SA) is a common condition in adults and children that causes disturbed sleep and daytime symptoms. It is characterised by disrupted breathing with disturbed sleep patterns. In adults this can lead to dangerous daytime sleepiness affecting for example driving performance. In children it may lead to hyperactivity in the day and poor school performance. There are a number of techniques for diagnosing the disorder but they can affect the quality of sleep which sometimes makes them inaccurate. Most are unsuitable for small children who cannot understand the value of the tests and tend to remove the monitoring wires and devices in the night. This study aims to validate a new non contact device "Safescan", based on low power radar technology, which can be put under a bed and record breathing patterns with no measuring device in contact with the sleeper. In this initial study the device will be validated in adults, against the gold standard of polysomnography (PSG) in the sleep laboratory at Royal Papworth Hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Able to give informed consent
排除标准
- •Patient with known sleep disordered breathing using a treatment device (e.g. continuous positive airway pressure) on the night of the study.
- •Polysomnography study records less than 4 hours of respiratory data
结局指标
主要结局
Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography
时间窗: overnight (8-10 hours)
Agreement in AHI +/- 10% between Safescan device and PSG. A comparison will be made between the 2 AHI's for each participant. The proportion in whom there is an agreement within +/- 10% will be reported.
次要结局
- Agreement between the Safescan device respiratory rate (RR) as breaths per minute overnight and RR from PSG(overnight (8-10 hours))
- Agreement in recorded body position between Safescan device and PSG(overnight (8-10 hours))
